# FDA recall Z-0944-2022

> **SML Distribution, LLC** · Class I · device recall initiated 2022-03-04.

## Product

Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test

## Reason for recall

The product was distributed without FDA authorization or clearance for marketing and distribution in the US.

## Distribution

US Nationwide distribution in the states of AL, FL, GA, MO, NY, TX, and WY.

## Key facts

- **Recall number:** Z-0944-2022
- **Recalling firm:** SML Distribution, LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-03-04
- **Report date:** 2022-05-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** tyrone, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0944-2022

## Citation

> AI Analytics. FDA recall Z-0944-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0944-2022. Source: US FDA. Licensed CC0.

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